US OKs some use of Prostrakan's cancer pain drug

Prostrakan Group Plc has won US approval - although with restrictions - for its cancer pain drug Abstral after repeated delays over safety concerns. The drug, a form of the opioid fentanyl, will be available only through registered doctors, pharmacies and distributors under a special risk management plan, the US Food and Drug Administration said on Friday.

Abstral aims to treat breakthrough pain in cancer patients who already use opioid pain medications continuously but need additional high doses of an opioid painkiller for a brief period. Delays over its approval have rocked the company in recent months, helping to prompt the resignation of its chief executive in September which also hurt shares of the British drugmaker.

Opioid drugs often prompt greater scrutiny and concerns because of their high potential for abuse. Side effects of Abstral include nausea, constipation, drowsiness and headache, the FDA said, although more serious problems including death have been seen with other similar medications that were given incorrectly. Prostrakan initially expected an FDA decision last June, but the agency twice said it needed more time.